A multicenter prospective randomized clinical trial was undertaken to compare a generic four-layer bandage system with a cohesive short-stretch system (Actico, Activa Healthcare) in the management of venous leg ulceration. Both systems are designed to produce sufficient pressure to counteract venous hypertension. Patients in leg ulcer services with leg ulceration were screened for inclusion in this trial. Patients with arterial disease (ankle brachial pressure index < 0.8) and causes of ulceration other than venous disease were excluded. For patients with bilateral ulceration, the limb with the larger area of ulceration was studied. Patients were randomized to receive either type of compression bandage and simultaneously randomized to one of two foam dressings that were changed weekly unless more frequent changes were clinically required. In all, 156 patients met entry criteria and were randomized from the 12 clinical centers with median (range) ulcer size of 4.33 (0.33-123.10) cm(2). Analysis revealed that after 24 weeks a total of 111 (71%) of patients had complete ulcer closure, 32 (21%) had withdrawn from the trial, 12 (8%) remained with open ulceration, and one patient had died. Of the 74 patients randomized to the four-layer bandage, 51(69%) had ulcer closure on treatment compared with 60/82 (73%) on the cohesive short-stretch system. Intention-to-treat analysis produced a hazard ratio for healing of 1.08 (95 percent CI 0.63-1.85, p= 0.79). Withdrawal rates were similar between groups (15, 20% four-layer bandage; 17, 21% cohesive short-stretch system). Ulcer closure rates for patients treated with the cohesive short-stretch system were similar to those for patients managed by the four-layer bandage system in this trial.

Objective: To evaluate health-related quality of life (HRQoL) in a prospective randomized trial of patients suffering from venous ulceration comparing a generic four-layer elastic bandage (4LB) with a new cohesive short stretch bandage system (CSSB). Methods: Randomized prospective open parallel groups trial in community leg ulcer clinics within twelve trusts in England and Northern Ireland. Patients newly presenting for treatment suffering from chronic venous ulceration, with ankle brachial pressure index (ABPI) >0.8 were entered into the trial. Patients were asked to complete the Nottingham Health Profile (NHP) at entry, at end of trial period (withdrawal or healing), and at 24 weeks. Principal analysis was the comparison of final NHP scores using linear regression with baseline scores entered as a covariate. Results: In all, 154 of the 156 patients who entered the trial completed the initial questionnaire, with 139/154 (90.2%) patients completing at least one follow-up questionnaire. Improvements were noted for all scores after 24 weeks. The improvements were significantly greater in the 114 patients whose ulcers had healed compared with the 40 whose ulcers remained open in the domains of bodily pain (mean difference [d]=13.2, 95% CI 3.6-22.9, P =0.008), emotional reactions (d=10.5, 95% CI 2.8-18.1, P =0.007) and social isolation (d=8.5, 95% CI 1.2-15.9, P =0.024). There were similar mean scores between the 72 patients treated with the 4LB and the 82 patients treated with CSSB for all domains of the NHP, the largest adjusted difference favoured CSSB for energy (d=3.6, 95% CI-4.3-11.4, P =0.37). Conclusions: Patients suffering from leg ulceration show improvements in perceived health following effective ulcer management. The two bandage systems achieved similar improvements in perceived health over 24 weeks.

Fifty-two patients (26 in each group) were recruited into this randomized, comparative, controlled trial of Rosidal K short-stretch compression bandage and SurePress long-stretch compression bandage in the treatment of venous leg ulcers. Patients were monitored for a maximum of 12 weeks. Each patient was seen weekly by a research nurse, who recorded the study variables. The mean percentage reduction in the wound bed surface area during the study period was 52% in the SurePress group and 73% in the Rosidal K group. Eight patients in each group saw their ulcers heal within the study period. The average limb volume reduction, based on the first 4 weeks of data collection, was 2.3 cm for those in the Rosidal K group and 3.9 cm in the SurePress group. Ulcer size increased in six patients allocated to SurePress bandages and in four patients allocated to Rosidal K bandages.

A multicenter prospective randomized clinical trial was undertaken to compare two foam dressings (Allevyn Hydrocellular, Smith & Nephew and Mepilex, Molnlycke Health Care AB) in the management of chronic venous leg ulceration. Patients were also randomized to two compression bandage systems (4-layer vs. cohesive short stretch) as a factorial design. Those with causes of ulceration other than venous disease were excluded. In all, 156 patients met the entry criteria and were randomized from the 12 clinical centers with a median (range) ulcer size of 4.33 (0.33-123.10) cm(2). After 24 weeks a total of 100 (64.1%) patients had complete ulcer closure, 46 (29.5%) had withdrawn from the trial, nine (5.8%) remained unhealed and one patient died. Of the patients randomized to Mepilex, 50/75 (66.7%) had complete ulcer healing compared with 50/81 (61.7%) on Allevyn. The hazard ratio for healing after adjustment for bandage type and trial center was 1.48 (95% C.I. 0.87-2.54, p=0.15), which only marginally changed following adjustment for baseline variables, neither of which achieved statistical significance (p=0.16). Withdrawal rates were similar between groups (23, 30.7% Mepilex vs. 23, 28.4% Allevyn). Pain improved following treatment with both dressings (p<0.001), but with no difference between dressings.